| Primary Device ID | 04251204325666 |
| NIH Device Record Key | d2510152-98ca-47ee-8e34-c5ef75475798 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | US IVD 48 Spot Target |
| Version Model Number | 8604532 |
| Catalog Number | 8604532 |
| Company DUNS | 318387958 |
| Company Name | Bruker Daltonik GmbH |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(877)442-2231 |
| ms.support.us@bruker.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04251204325666 [Primary] |
| PEX | System, mass spectrometry, maldi tof, microorganism identification, cultured isolates |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-02-25 |
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